Treatment or prevention of new-onset type 1 diabetes with baricitinib

Abstract

The present invention provides methods of treating or preventing new-onset type 1 diabetes with baricitinib, either alone or in combination with insulin, insulin analogues and/or other immunomodulatory agent.

We claim: 
     
         1 . A method of treating or preventing new-onset type 1 diabetes in a subject, comprising administering an effective amount of baricitinib, or a pharmaceutically acceptable salt thereof. 
     
     
         2 . The method according to  claim 1  wherein the new-onset type 1 diabetes is type 1 diabetes clinically diagnosed according to American Diabetes Association guidelines (ADA) within the 100 days prior to treatment commencement. 
     
     
         3 . The method according to  claim 1  further comprising the administration of an effective amount of insulin, an insulin analogue, and/or other immunomodulatory agents. 
     
     
         4 . The method according to  claim 1 , wherein the amount of baricitinib or a pharmaceutically acceptable salt thereof is 0.5 to 10 mg, 0.5 to 8 mg, 0.5 to 6 mg, 0.5 to 4 mg, 1 to 4 mg, and 2 to 4 mg. 
     
     
         5 . The method according to  claim 1 , wherein the amount of baricitinib or a pharmaceutically acceptable salt thereof is 2 to 4 mg. 
     
     
         6 . The method according to  claim 1 , wherein the amount of baricitinib or a pharmaceutically acceptable salt thereof is selected from 0.5 mg, 1 mg, 1.5 mg, 2 mg, 2.5 mg, 3 mg, 3.5 mg, 4 mg, and 4.5 mg, 5 mg, 5.5 mg, 6 mg, 6.5 mg, 7 mg, 7.5 mg, 8 mg, 8.5 mg, 9 mg, 9.5 mg, and 10 mg. 
     
     
         7 . The method according to  claim 1 , wherein the amount of baricitinib or a pharmaceutically acceptable salt thereof is 1 mg. 
     
     
         8 . The method according to  claim 1 , wherein the amount of baricitinib or a pharmaceutically acceptable salt thereof is 2 mg. 
     
     
         9 . The method according to  claim 1 , wherein the amount of baricitinib or a pharmaceutically acceptable salt thereof is 4 mg. 
     
     
         10 . The method according to  claim 1 , wherein baricitinib or a pharmaceutically acceptable salt thereof is administered orally. 
     
     
         11 . The method according to  claim 1 , wherein baricitinib or a pharmaceutically acceptable salt thereof is administered once daily. 
     
     
         12 . The method according to  claim 1 , wherein baricitinib is administered as the free base. 
     
     
         13 . The method according to  claim 1 , wherein baricitinib or a pharmaceutically acceptable salt thereof is administered as a pharmaceutical composition comprising baricitinib or a pharmaceutical salt thereof with one or more pharmaceutically acceptable carriers, diluents, or excipients. 
     
     
         14 . The method according to  claim 13 , wherein the pharmaceutical composition comprises baricitinib free base. 
     
     
         15 . The method according to  claim 13 , wherein the pharmaceutical composition is in a form selected from a pill, a tablet, a solution, and a suspension.